Contact Lenses Form

Clinical Review Criteria Related to Contact Lenses (Formerly Scleral Lens) Effective 12/1/2022 (Date of Last Review: 9/13/2022) Page 1 of 8 © 2007 Health New England

Clinical Review Criteria Related to Contact Lenses (Formerly Scleral Lens):

Definitions:

• Corneal Contact Lens/Liquid Bandage: A fluid-ventilated, oxygen-permeable lens that vaults over the cornea and helps manage ocular surface disease. Used for post cataract surgery with intraocular lenses (IOL), treatment of aphakia, keratoconus, moisture barrier (for keratitis, corneal edema, dry eyes). • Prose (Prosthetic Replacement Ocular Surface Ecosystem) Lens: Scleral contact lens for complex corneal conditions including dry eye disease (DED). • Scleral Contact Lens (CPT-92317): A large diameter rigid gas permeable lens that rests on the sclera and creates a tear-filled vault over the cornea. Used for treatment of reddened eyes that are shrunken by inflammatory disease or sightlessness, dry eyes. • Scleral Shell or Shield: (Catchall term for different types of hard scleral contact lenses) Fits over the entire exposed surface of the eye underneath the eyelids. It functions as a protective barrier against tear evaporation. Used as an artificial support and a protective covering for diseased eye or sightless or shrunken eye. • Therapeutic Soft Hydrophilic Contact Lenses are made of poly-2-hydroxyethyl methacrylate and other flexible plastics.
• Sclera: Clear covering over white of the eye. • Cornea: Clear covering over pupil and iris. • Epithelium: Layer of tissue that covers the cornea and conjunctiva. (Regenerates every 3-10 days in healthy eyes and damaged eyes in ocular surface disease, treatment is dependent on the cause.) • Absorptive Contact Lenses: Tinted lenses that are used to improve a member’s visual clarity.
This is done by reducing glare and increasing contrast. The percentage refers to the amount of light passing through the lens. See reference below for additional information. • Gas Permeable Scleral Lenses: Rigid lenses made of durable plastics that allow oxygen to pass through the lens. Lenses also are called GP lenses, rigid gas permeable lenses, RGP lenses and oxygen permeable lenses.

Policy:

Contact Lenses are for correction of vision disturbance or for the treatment of disease or replacement of the lens of the eye. Contact lenses are generally not covered for vision correction.
Coverage is subject to member benefit limits and exclusions.

I. General Criteria for Approval: Medicare and Commercial

The following services for scleral, gas permeable and corneal contact lenses are covered in the following situations:

A. All contact lens fitting codes (CPT 92310-92326)

B. Aphakia (V2500-V2599) (absence of the natural lens)

Clinical Review Criteria Related to Contact Lenses (Formerly Scleral Lens) Effective 12/1/2022 (Date of Last Review: 9/13/2022) Page 2 of 8 © 2007 Health New England

1. For contact lenses and glasses following cataract surgery with the insertion of an intraocular lens, refer to the member’s benefit plan description.

2. Medicare Advantage members with aphakia who have not had an intraocular lens replacement meet medical necessity criteria for a corneal lens.

   II.
   Therapeutic Hydrophilic Contact Lenses (Corneal Bandage) (V2520, V2530, V2531)

   A. Therapeutic soft (hydrophilic) contact lenses or gas-permeable fluid-ventilated scleral lenses may be considered medically necessary when used as moist corneal bandages for the treatment of acute corneal abrasion, corneal ulcers and erosion, poorly healing eye wounds, or for other therapeutic reasons including but not limited to:

3. Corneal ectatic disorders:

   a. Ectasia, post-surgery (irregularities in the cornea leading to disturbances of vision as a result of astigmatism) b. Fuchs’ superficial marginal keratitis (cells in the cornea’s inner layer gradually deteriorate with unknown cause) c. Keratoconus (progressive thinning of the cornea) d. Keratoglobus (rare, degenerative non-inflammatory disorder of eye causing corneal thinning) e. Pellucid marginal degeneration (clear bilateral thinning (ectasia) in the inferior and peripheral region of the cornea) f. Terrien’s marginal degeneration (painless, slowly progressive thinning of the peripheral corneal stroma)

4. Corneal scarring and/or vascularization

5. Irregular corneal astigmatism (a refractive error, it is not an eye disease, that causes blurred vision. Blurred vision is due to an irregularly shaped cornea or because of curvature of lens inside the eye.) after keratoplasty or other corneal surgery

6. Ocular surface disease with pain and/or decreased visual acuity:

   a. Dry eye, severe b. Epithelial defects, persistent c. Exposure keratopathy (eyelid does not protect the cornea enough) d. Graft vs. host disease e. Mucous membrane pemphigoid (blisters that form on the mucous membranes) f. Neurotrophic keratopathy (degenerative corneal disease induced by trigeminal nerve impairment) g. Post-ocular surface tumor excision h. Post-glaucoma filtering surgery

7. Stevens Johnson syndrome sequelae (varies between mild mucopurulent conjunctivitis and severe perforating corneal ulcers)

   B. Scleral Shell/Scleral Contact Lenses (Cover Shell) (V2627): Lenses considered medically necessary under member’s medical benefit, when all of the following are met:

Clinical Review Criteria Related to Contact Lenses (Formerly Scleral Lens) Effective 12/1/2022 (Date of Last Review: 9/13/2022) Page 3 of 8 © 2007 Health New England

1. Member has keratoconus; AND

2. Member is unable to be fitted for a conventional contact lens; AND

3. Treatment of an eye rendered sightless and shrunken by inflammatory disease; AND

4. Treatment of “dry eye” where the device serves as a substitute for the function of the diseased lacrimal gland such as keratoconjunctivitis sicca

   C. Conventional Contact Lens (V2500, V2501 V2503, V2510, V2511, V2512, V2520, V2521, V2522, V2599)

   Contact Lenses are for correction of vision disturbance or for the treatment of diseas replacement of the lens of the eye. Contact lenses are generally not covered for vision correction. Coverage is subject to member benefit limits and exclusions.

   D. Gas permeable scleral lenses are used for:

5. Post-cataract surgery with insertion on intraocular lenses

6. Treatment of aphakia (absence of the natural lens)

7. As a moist corneal bandage for treatment of acute or chronic corneal pathology including:

   a. Bullous keratopathy b. Dry eyes c. Corneal ulcers and erosion d. Keratitis e. Corneal edema f. Descemetocele (area of extreme focal corneal thinning) g. Corneal ectasis h. Mooren's ulcer (eye condition that causes damage to and degeneration of the cornea, extremely rare) i. Anterior corneal dystrophy j. Neurotrophic keratoconjunctivitis (degenerative disease characterized by corneal sensitivity reduction with spontaneous epithelium breakdown and impairment of corneal healing)

8. For treatment of keratoconus (irregular protrusion/thinning of the cornea)

   E. Scleral Contact Lenses (Cover shell): Prior Approval Required

9. Treats eyes rendered sightless and shrunken by inflammatory disease. Scleral shell may avoid surgical enucleation (removal of eye) and prosthetic implant and also act to support the surrounding orbital tissue.

10. When used in combination with artificial tears in the treatment of “dry eye” of diverse etiology

Clinical Review Criteria Related to Contact Lenses (Formerly Scleral Lens) Effective 12/1/2022 (Date of Last Review: 9/13/2022) Page 4 of 8 © 2007 Health New England

3. Covered for members for whom corneal transplant surgery is the only alternative treatment option available for:

   a. Keratoconus b. Corneal transplants in which the healing resulted in warpage of the graft and abnormal astigmatism c. Scars due to injury, dystrophies or degenerative diseases

   F. PROSE Scleral Lens (CPT V2627): Prior Approval Required

4. Reviewed on a case-by-case basis due to conflicting studies on use of PROSE

5. May be considered medically necessary under the medical benefit for patients who have not responded to topical medications or standard spectacle or contact lens fitting, for the following conditions:

   a. Corneal ectatic disorders (e.g., keratoconus, keratoglobus, pellucid marginal degeneration, Terrien marginal degeneration, Fuchs’ superficial marginal keratitis, postsurgical ectasia);
   b. Corneal scarring and/or vascularization;
   c. Irregular corneal astigmatism (e.g., after keratoplasty or other corneal surgery); d. Ocular surface disease (e.g., severe dry eye, persistent epithelial defects, neurotrophic keratopathy, exposure keratopathy, graft vs host disease, sequelae of Stevens Johnson syndrome, mucous membrane pemphigoid, postocular surface tumor excision, postglaucoma filtering surgery) with pain and/or decreased visual acuity.

   III. Not Covered: Medicare and Commercial

   (Note - Some may be covered under a separate vision plan/benefit.)

   A. Use of lenses that are not noted above

   B. Miscellaneous fitting costs associated with the PROSE lenses

   C. Contact lenses used in the treatment of non-diseased eyes for refractive changes

   D. Replacement lenses with no change in the member’s vision E. Lenses for diagnosis and treatment of dry eyes F. Replacement of lenses due to loss or damage G. Corrective contact lenses for astigmatism H. EyePrintPRO™ - There is insufficient published evidence to assess the safety and/or impact on health outcomes or patient management of the EyePrintPRO™ scleral shell on treatment of refractory corneal diseases or conditions.

   I. Scleral lens for the diagnosis of glaucoma, cataract, optic atrophy, macular degeneration, retinitis pigmentosa or diabetes-related vision problems

Clinical Review Criteria Related to Contact Lenses (Formerly Scleral Lens) Effective 12/1/2022 (Date of Last Review: 9/13/2022) Page 5 of 8 © 2007 Health New England

J. Corneal scarring and anterior corneal dystrophies K. Scleral lens is not medically necessary in members with conditions not severe enough to warrant corneal transplant.

L. Cost of supplies used to clean or maintain lenses

M. Coverage of more than one set of contact lenses per benefit year - See individual benefit plan.

IV. Medically Necessary for MassHealth Members (MassHealth pays for hard, soft or gas permeable contact lenses) who meet one or more of the following conditions:

A. Anisometropia (unequal refractive between eyes) of more than 3.00 diopters

B. Postoperative cataract extraction

C. Keratoconus

D. Hyperopia (farsightedness) of more than 7.00D

E. Myopia (nearsightedness) of more than 7.00D

For additional information: https://www.mass.gov/lists/vision-care-manual-for-masshealth-providers

V.
Required Documentation

A. A comprehensive evaluation of the corneal disorder which includes an ophthalmological examination, corneal topographic modeling and fitting of scleral lenses

B. Specific clinical documentation from treating physician to support medical necessity of lenses

C. For scleral lens, documentation of attempt to use a conventional contact lens with an unfavorable response and clear documentation why a conventional lens cannot be used.

VI.
Not Covered under MassHealth

A. Absorptive lenses of greater than 25 percent absorption (See citations below for additional information.);

B. Prisms obtained by decentration;

C. Treatment of congenital dyslexia (The Massachusetts Department of Education may offer resources for the treatment of this condition.);

Clinical Review Criteria Related to Contact Lenses (Formerly Scleral Lens) Effective 12/1/2022 (Date of Last Review: 9/13/2022) Page 6 of 8 © 2007 Health New England

D. Routine adjustments or follow-up visits to check visual acuity and ocular comfort (Payment for such visits is included in the dispensing fee for six months after the date on which the eyeglasses were dispensed.);

E. Contact lenses for extended-wear use;

F. Invisible bifocals/no line progressive lenses; and

G. Substitutions (i.e., designer frames - member to pay entire cost of glasses)

VII. Eyeglasses

A. MassHealth pays for an extra or spare eyeglasses with PA only and must meet 1 on the following:

1. Aphakia

2. More than 7.00 D of myopia or hyperopia

3. More than 3.00D astigma

   HCPCS Codes:

   V2500 Contact lens, PMMA, spherical, per lens V2501 Contact lens, PMMA, toric or prism ballast, per lens V2503 Contact lens, PMMA, color vision deficiency, per lens V2510 Contact lens, gas permeable, spherical, per lens V2511 Contact lens, gas permeable, toric, prism ballast, per lens V2512 Contact lens, gas permeable, bifocal, per lens V2520 Contact lens, hydrophilic, spherical, per lens V2521 Contact lens, hydrophilic, toric or prism ballast, per lens (EXCLUSION) V2522 Contact lens, hydrophilic, bifocal, per lens V2599 Contact lens, other type V2530 Contact lens, scleral, gas impermeable, per lens V2531 Contact lens, scleral, gas permeable, per lens V2627 Scleral cover shell

   CPT Codes: NO PA Covered only when member meets criteria for contact lenses

   92071 Fitting of contact lens for treatment of ocular surface disease 92310 Prescription of optical and physical characteristics of and fitting of contact lens, with medical supervision of adaptation; corneal lens, both eyes, except for aphakia 92311 Prescription of optical and physical characteristics of and fitting of contact lens, with medical supervision of adaptation; corneal lens for aphakia, 1 eye 92312 Prescription of optical and physical characteristics of and fitting of contact lens, with medical supervision of adaptation; corneal lens for aphakia, both eyes,

Clinical Review Criteria Related to Contact Lenses (Formerly Scleral Lens) Effective 12/1/2022 (Date of Last Review: 9/13/2022) Page 7 of 8 © 2007 Health New England

92313 Prescription of optical and physical characteristics of and fitting of contact lens, with medical supervision of adaptation; corneoscleral

92314 Prescription of optical and physical characteristics of contact lens, with medical supervision of adaptation and direction of fitting by independent technician; corneal lens both eyes except for aphakia 92315 Prescription of optical and physical characteristics of contact lens, with medical supervision of adaptation and direction of fitting by independent technician; corneal lens for aphakia, 1 eye 92316 Prescription of optical and physical characteristics of contact lens, with medical supervision of adaptation and direction of fitting by independent technician; corneal lens for aphakia, both eyes 92317 Prescription of optical and physical characteristics of contact lens, with medical supervision of adaptation and direction of fitting by independent technician; corneoscleral lens 92325 Modification of contact lens (separate procedure), with medical supervision of adaptation 92326 Replacement of contact lens

Medical Criteria Disclaimer:

Property of Health New England. All rights reserved. The treating physician or primary care provider must submit to Health New England the clinical evidence that the patient meets the criteria for the treatment, testing or surgical procedure. Without this documentation and information, Health New England will not be able to properly review the request for prior authorization. The clinical review criteria reflect how Health New England determines whether certain services or supplies are medically necessary. Health New England established the clinical review criteria based upon a review of currently available clinical information (including clinical outcome studies in the peer- reviewed published medical literature, regulatory status of the technology, evidence-based guidelines of public health and health research agencies, evidence-based guidelines and positions of leading national health professional organizations, views of physicians practicing in relevant clinical areas, and other relevant factors). Health New England expressly reserves the right to revise these conclusions as clinical information changes, and welcomes further relevant information. Each benefit program defines which services are covered. The conclusion that a particular service or supply is medically necessary does not constitute a representation or warranty that this service or supply is covered and/or paid for by Health New England, as some programs exclude coverage for services or supplies that Health New England considers medically necessary. If there is a discrepancy between this guideline and a member's benefits program, the benefits program will govern. In addition, coverage may be mandated by applicable legal requirements of a state, the Federal Government or the Centers for Medicare & Medicaid Services (CMS) for Medicare Advantage and Medicaid members. Health New England has adopted the herein policy in providing management, administrative and other services to its Health Plan.

REFERENCES:

NCQA Standard, UM 2, Clinical Criteria for Utilization Management Decisions, Element A

Clinical Review Criteria Related to Contact Lenses (Formerly Scleral Lens) Effective 12/1/2022 (Date of Last Review: 9/13/2022) Page 8 of 8 © 2007 Health New England

National Coverage Determination (NCD) for scleral shell (80.5). (n.d.). Retrieved June 22, 2022, from

https://www.cms.gov/medicare-coverage-database/details/ncd- details.aspx?MCDId=15&ExpandComments=n&McdName=Thomson Micromedex DrugPoints Compendium Revision Request-CAG-00390&NCDId=235

CMS.gov

Medicare Coverage Database, Retrieved June 22, 2022, from:

  https://www.cms.gov/medicare-coverage-database/new-search/search.aspx

Koppen, C., Kreps, E. O., Anthonissen, L., Van Hoey, M., Dhubhghaill, S. N., & Vermeulen, L. (2018, January). Scleral Lenses Reduce the Need for Corneal Transplants in Severe Keratoconus. Retrieved June 22, 2022, from

https://www.ajo.com/article/S0002-9394(17)30453-1/fulltext

American Journal of Ophthalmology, Volume 185, Pages 43-47

Common Corneal Diseases-Corneal Diseases that may require a Transplant. (n.d.).

Retrieved June 22, 2022, from

https://restoresight.org/cornea-donation/descriptions-of-diseases/

Eye Bank Association of America

Jedlicka, J., OD. (2018, August 20). Scleral GP contact lenses: How these can help you.

Retrieved June 22, 2022, from

https://www.allaboutvision.com/contacts/scleral-lenses.htm

All About Vision

Absorptive Lenses, Retrieved June 22, 2022, from:

  https://extradefaultspecialty.ecpbuilder.com/unfinished-pages/absorptive-lenses/

Basic Information of Absorptive Lenses from Open Access Journal of Ophthalmology, publish date July
20, 2018, Retrieved June 22, 2022, from:

https://medwinpublishers.com/OAJO/OAJO16000S1-003.pdf

Alexandro Rodriguez De Los Reyes, R , BostonSight PROSE (Prosthetic Replacement of the Ocular Surface Ecosystem) and Scleral Contact Lenses, American Academy of Ophthalmology. Retrieved June 21, 2022, from:

BostonSight PROSE (Prosthetic Replacement of the Ocular Surface Ecosystem) and Scleral Contact Lenses - EyeWiki (aao.org)

Vision Services and Medical Coverage for Ocular Disease-Medical Policy-Blue Cross Blue Shield of Vermont. Retrieved July 13, 2022, from,
https://www.bluecrossvt.org/documents/vision-services-and-medical-coverage-jul2022

Date Policy Changes 2/2022 • Codes V2530 and V2531 require PA • Code 92071 added to policy 5/2022 • Code V2627 requires a PA 7/2022 • II. Therapeutic Hydrophilic Contact Lenses (Corneal Bandage) (V2520, V2530, V2531), clarified PROSE lens criteria • Added 2 references